The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning Lumenis VersaCut Tissue Morcellator manufactured by Lumenis Limited. The affected model numbers are 0637-245-01 (starter kit) and 0636-470-01 (Control Box) which includes all products since initial product release in 1998.
Lumenis is recalling certain models of VersaCut Morcellator devices to perform corrective labeling as a result of three reported events of air embolism secondary to incorrect reversal tubing system hook-up.
For details, please visit the following FDA website:
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0795-2013&w=02202013&lang=eng
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 25 February 2013